by Peter Freiberg

With the deadline for public comment just three weeks away on proposed federal regulations covering sperm donors, Gay activists say they are still concerned two of the regulations might restrict the ability of Lesbians to have children using sperm donated by Gay men.

The two regulations in the Food and Drug Administration’s proposed procedures for "directed donors" — men who donate sperm to a woman they know — are part of a longer proposal on which the FDA is seeking public comment by Dec. 29. The proposed regulations are part of the agency’s efforts to establish some oversight into a rapidly growing market for "human cellular and tissue-based products" to be used for medical repairs and donations of such body organs and tissue as corneas, skin, and sperm.

The FDA’s plan has drawn some praise from activists because it does open the way for "unsuitable" donors to be allowed to donate sperm to women they know. But one regulation would make it virtually impossible for a Lesbian to use fresh sperm donated by a Gay man. Women could use sperm from a Gay man only after it has been frozen for six months, and some activists say frozen sperm is much less effective in insemination.

A second regulation would require that a doctor approve insemination with sperm from any so-called "unsuitable" donors. The FDA has not yet defined what an "unsuitable" donor is, except to say "a donor whose specimen tests repeatedly reactive or positive on a test required under [the proposed regulations] must be determined to be unsuitable."

The FDA states that it is not specifying the "risk factors" for which it will screen because, state the proposed regulations, "these may change as knowledge of communicable diseases grows."

"FDA, together with CDC, is reviewing the risk factors for transmission of relevant communicable diseases in light of current scientific knowledge," states the proposal. "Based on the results of the review, FDA plans to specifically describe in a guidance document risk factors and screening information to assist … in complying with the regulation."

The proposed FDA rules would be an improvement over rules now in effect in most places in the absence of federal regulations, says Doni Gewirtzman, an attorney at Lambda Legal Defense and Education Fund who is drafting a joint letter to the FDA about the proposed regulations. New York, for example, flatly bans all Gay men as directed or anonymous donors, and activists say virtually all private sperm banks employ similar bans.

But activists said they believe the definition will likely include Gay men and men with HIV infection and that the homophobia of many doctors would lead them to withhold approval for no rational reason.

Under the FDA proposal, in order to use a directed donor’s sperm fresh, a woman must have been sexually intimate with the donor. If the donor and recipient have not been sexually intimate, then after testing for HIV antibodies, the sperm would have to be frozen and quarantined for six months (currently, freezing and quarantining is done on anonymous donations only).

After six months, the donor would then be re-tested for HIV antibodies. If he tested negative, the sperm would be made available to the woman for insemination. For added protection, this six-month freezing period is more than the average time it takes the body to begin producing antibodies after it has been infected by HIV. Generally, the body begins producing HIV antibodies within one to three months.

Many, if not most, heterosexual women are inseminated with sperm from their sexual partner — husband or boyfriend — when undergoing fertility treatment. But since very few Lesbians are sexually intimate with the men they wish to receive donated sperm from, they would almost always be barred from using fresh sperm.

"What we will suggest," said Gewirtzman, "is that, with full informed consent … anybody should be able to use fresh sperm with a directed donation, regardless of whether they’ve been sexually intimate with the donor or not."

"By insuring accessible [donor] insemination services," said Gewirtzman, "we insure that Lesbians and Gay men will be able to construct the types of families they want to have."

Christopher Anders, legislative counsel in Washington to the American Civil Liberties Union, one of the groups involved in the joint letter, said the "sexually intimate" requirement would also hurt heterosexuals — say, a couple who want to use the man’s brother as a sperm donor. Here, too, the sperm would have to be frozen, since the recipient and donor were not sexually intimate.

"It does really go to a woman’s right to make a decision as to who will be the biological father of her child," Anders said.

Gewirtzman says the other FDA rule, which would require a physician’s approval if a recipient wants to use an "unsuitable" directed donor, should be eliminated.

"It could potentially allow doctors to use impermissible factors to withhold their consent," Gewirtzman says, such as "concerns about the sexual orientation of the donor, the sexual orientation of the recipient, or the HIV status of the donor."

Maureen O’Leary, executive director of the Gay and Lesbian Medical Association, another group that is expected to sign the joint letter, said such discrimination is real.

"We certainly know there is discrimination against Gay and Lesbian patients, and I can’t say that this [approval of insemination] would be any different," said O’Leary.

But O’Leary said her organization is still considering the best way to structure the decision-making process for women using directed donors.

In its proposal, the FDA asks for comment on whether the rules should be broadened to permit a woman "to select an anonymous donor with a known high risk behavior."

The full text of the FDA’s proposal can be read in the Sept. 30 Federal Register (pages 52696-52723), available in most libraries, or on the Federal Register Web site (www.fda.gov/cber/rules/suitdonor.txt).

The possibility that all Gay men would be barred from being anonymous donors under FDA regulations drew criticism last spring from a group of activists and sperm bank directors.

Those activists said then that there was no scientific or medical basis for sperm banks excluding Gay men as anonymous donors while accepting heterosexual men who might engage in high-risk practices.

Because all anonymous sperm donations are frozen and quarantined for six months, followed by retesting of donors, "Gay men should be allowed to donate sperm [anonymously], because safeguards are in place to screen out infectious disease," said Leland Traiman, executive director of the Oakland, Calif.-based Rainbow Flag Health Services and Sperm Bank,

There have been eight cases of AIDS as a result of donor insemination reported to the U.S. Centers for Disease Control and Prevention as of 1996, according to researchers at the CDC’s Division of HIV/AIDS Prevention reported. Six of the cases have been documented and two cases are considered possibly attributable to insemination. The report appeared in the April issue of Obstetrics and Gynecology and summarized a review of HIV/AIDS surveillance data from 1980 to 1996.

Gewirtzman said Lambda and the other groups forming a letter to the FDA decided to focus their initial comments on the directed donor procedures, the "vehicle by which many Lesbians and Gay men decide to form families." He said they would wait until the FDA defines "suitable" and "unsuitable" donors before dealing with the issue of anonymous donors.

Lenore Gelb, a spokesperson for the FDA, said she does not know when the "guidance document" outlining "suitable" and "unsuitable" donors will be issued. Determining who falls into these categories, Gelb said, will be based on the latest scientific evidence.

Whenever the "guidance" is issued, Gelb said, there will be another period for comment and possibly a workshop held by the FDA to get public input. Eventually, a final rule will be adopted, but Gelb said she has no idea when that would be.

"Nothing has happened … that changes anything for the near future," said Gelb, asserting that the FDA is open to making changes in all its proposals.

According to Lambda’s Gewirtzman, groups that are cooperating on a joint letter to FDA are Lambda, the ACLU, GLMA, the National Center for Lesbian Rights, the Human Rights Campaign, Traiman’s Rainbow Flag sperm bank, and the Oakland-based Sperm Bank of California.

The ACLU’s Anders says he believes the FDA and the Department of Health and Human Services (under which the FDA is organized) "will listen to the community that makes use of sperm banks, as well as to the sperm bank operators, and will be responsive."

"I’m fairly optimistic," says Anders, "that these comments are going to be taken seriously and that this rule will be a better rule when all is done."

"For the Lesbian and Gay parents we work with," says Kate Kendell, executive director of the National Center for Lesbian Rights, "the ability to have choice in forming their families is a very important one."

Members of the public who wish to submit comments on the FDA proposal should submit them in writing by Dec. 29 to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

This article appeared in the issue of:
December 3, 1999